Phase
Condition
Blepharitis
Treatment
Lotilaner ophthalmic solution, 0.25%
Vehicle control
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be willing to sign the informed consent form and is deemed capable of complying withthe requirements of the study protocol
Must meet the following criteria in at least one eye: Have more than 10 eyelashes (Grade 2 or higher) with collarettes on the upper or lower eyelid; have at leastGrade 1 erythema of the lower eyelid; and have a total meibomian gland secretionscore ≥ 12 but ≤ 32 AND have a minimum of 6 expressible glands for the 15 glandsevaluated on the lower eyelid
Currently wearing soft contact lenses on both eyes an average of at least 2 days perweek with an average minimum wearing time of 6 hours each day over the past 3 monthsand is able and willing to continue to wear contact lenses during the study
Exclusion
Exclusion Criteria:
Use of artificial tears or rewetting drops within 24 hours of the Screening visit orunwilling to forego the use of this treatment during the study
Prescription AND systemic, drug delivery implant, ocular topical, or topical:antibacterial, anti-parasitic, or anti-inflammatory corticosteroid treatment within 14 days of the Screening or Day 1 visits
Use of TYRVAYA™ Nasal Spray (varenicline solution, Oyster Point Pharma) within 14days of the Screening visit or unwilling to forego the use of this treatment duringthe study
Use of XDEMVY™ (lotilaner ophthalmic solution) 0.25%, Tarsus Pharmaceuticals, Inc.,within 12 months of the Screening visit
Treatment for blepharitis (e.g., tea tree oil-based products, hypochlorousacid-based products, commercial eyelid foams, eyelid wipes, lid scrubs, etc.) within 14 days of the Screening visit or unwilling to forego the use of these treatmentsduring the study
Use of artificial eyelashes or eyelash extensions at the Screening visit if theylimit accurate eyelid margin assessment
Currently pregnant or lactating
Study Design
Study Description
Connect with a study center
Site
Cave Creek, Arizona 85331
United StatesSite Not Available
Site
Long Beach, California 90805
United StatesSite Not Available
Vision Institute
Colorado Springs, Colorado 80907
United StatesSite Not Available
Site
Delray Beach, Florida 33484
United StatesSite Not Available
Site
Indianapolis, Indiana 46240
United StatesSite Not Available
Site
Pittsburg, Kansas 66762
United StatesSite Not Available
Site
Louisville, Kentucky 40206
United StatesSite Not Available
Site
Edina, Minnesota 55436
United StatesSite Not Available
Site
Shelby, North Carolina 28150
United StatesSite Not Available
Site
Fargo, North Dakota 58103
United StatesSite Not Available
Site
Powell, Ohio 43065
United StatesSite Not Available
Site
Cranberry Township, Pennsylvania 16066
United StatesSite Not Available
Site
Memphis, Tennessee 38104
United StatesSite Not Available
Site
Houston, Texas 77005
United StatesSite Not Available
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